Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes - Tabular View

Tracking Information
First Received Date ^ICMJE	September 9, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	October 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00045786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes
Official Title ^ICMJE
Brief Summary	The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Myelodysplastic Syndrome
Intervention ^ICMJE	Drug: CC-1088
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	39
Completion Date	November 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related. Patient must be able to adhere to the study visit schedule and other protocol requirements. Patient must understand and voluntarily sign an informed consent document. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. Women must not be pregnant or lactating.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00045786
Responsible Party
Study ID Numbers ^ICMJE	CC-1088-MDS-801-001
Study Sponsor ^ICMJE	Celgene Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Celgene Corporation
Verification Date	May 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP